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Meta-analysis of Randomized Clinical Trials

Monica R. Shah, MD, MHS, MSJ; Vic Hasselblad, PhD; Lynne W. Stevenson, MD; Cynthia Binanay, RN, BSN; Christopher M. O’Connor, MD; George Sopko, MD, MPH; Robert M. Califf, MD

JAMA. 2005;294:1664-1670.

Context  Randomized clinical trials (RCTs) evaluating the pulmonary artery catheter (PAC) have been limited by small sample size. Some nonrandomized studies suggest that PAC use is associated with increased morbidity and mortality.

Objective  To estimate the impact of the PAC device in critically ill patients.

Data Sources  MEDLINE (1985-2005), the Cochrane Controlled Trials Registry (1988-2005), the National Institutes of Health ClinicalTrials.gov database, and the US Food and Drug Administration Web site for RCTs in which patients were randomly assigned to PAC or no PAC were searched. Results from the ESCAPE trial of patients with severe heart failure were also included. Search terms included pulmonary artery catheter, right heart catheter, catheter, and Swan-Ganz.

Study Selection  Eligible studies included patients who were undergoing surgery, in the intensive care unit (ICU), admitted with advanced heart failure, or diagnosed with acute respiratory distress syndrome and/or sepsis; and studies that reported death and the number of days hospitalized or the number of days in the ICU as outcome measures.

Data Extraction  Information on eligibility criteria, baseline characteristics, interventions, outcomes, and methodological quality was extracted by 2 reviewers. Disagreements were resolved by consensus.

Data Synthesis  In 13 RCTs, 5051 patients were randomized. Hemodynamic goals and treatment strategies varied among trials. A random-effects model was used to estimate the odds ratios (ORs) for death, number of days hospitalized, and use of inotropes and intravenous vasodilators. The combined OR for mortality was 1.04 (95% confidence interval [CI], 0.90-1.20; P = .59). The difference in the mean number of days hospitalized for PAC minus the mean for no PAC was 0.11 (95% CI, –0.51 to 0.74; P = .73). Use of the PAC was associated with a higher use of inotropes (OR, 1.58; 95% CI, 1.19-2.12; P = .002) and intravenous vasodilators (OR, 2.35; 95% CI, 1.75-3.15; P<.001).

Conclusions  In critically ill patients, use of the PAC neither increased overall mortality or days in hospital nor conferred benefit. Despite almost 20 years of RCTs, a clear strategy leading to improved survival with the PAC has not been devised. The neutrality of the PAC for clinical outcomes may result from the absence of effective evidence-based treatments to use in combination with PAC information across the spectrum of critically ill patients.

Author Affiliations: Department of Cardiology, Columbia University Medical Center, New York, NY (Dr Shah); Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC (Dr Hasselblad); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Mass (Dr Stevenson); Project Leadership, Duke Clinical Research Institute, Durham, NC (Ms Binanay); Division of Cardiology, Duke University Medical Center, and Duke Clinical Research Institute, Durham, NC (Drs O’Connor and Califf); and Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (Dr Sopko).

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